In the wake of New Zealand’s proposed ban on direct-to-consumer drug advertising (DTCA), the issue has reared its head again in the United States, with experts outside industry split on whether the ads should be allowed to continue.

If New Zealand’s ban goes through, the United States would be the only industrialized country to allow such ads. In commentaries released Monday, some who have closely monitored DTCA said the ads have beneficial effects and should be allowed, albeit in a regulated fashion.

But others maintain that DTCA poses a net harm to public health and should be banned outright.

“The question for U.S. policymakers is not whether DTCA should be banned, but how can its benefits be maximized and risks minimized within our free enterprise system,” Richard Kravitz, of the center for health services in primary care at the University of California at Davis, wrote in the March issue of PLoS Medicine.

“DTCA is neither good nor evil; it is both,” Kravitz wrote. “A little regulatory ingenuity could harness the enormous power of DTCA or DTCA-like public service announcements to improve the public health.”

Kravitz argued that a policy requiring a two-year moratorium on DTCA of new drugs and post-marketing surveillance “could avoid another Vioxx tragedy, in which drug marketing got well ahead of the science.”

He also recommended a tax system to create incentives for public-private consortia to generate mass-media campaigns to educate consumers about serious medical conditions and encourage them to take evidence-based therapies.

Elizabeth Almasi and Randall Stafford, both of the Stanford Prevention Research Center, argued that the ads can have a beneficial placebo effect that might increase the clinical effectiveness of the advertised product by teaching viewers what to expect from the medication.

“This seldom-discussed effect of DTCA should be taken into account in discussion of policy approaches to this form of marketing,” Almasi and Stafford wrote in the journal.

As examples, the researchers cite two commercials: an ad for Schering-Plough’s Claritin that depicts “the joy of playing in beautiful fields for allergy sufferers” and an ad for Merck’s Vioxx that shows elderly patients with arthritis participating in their favorite activities.

“Patients who take the advertised medication may be conditioned to elicit the positive feelings that were portrayed in the advertisement, which could enhance the medication’s clinical effect,” Almasi and Stafford wrote.

Stafford acknowledged in an interview with United Press International that the placebo effect of the ads has not been proven. “It’s really speculative in some sense … but we feel that there’s a high likelihood that such an effect is going on,” he said.

Almasi and Stafford go on to note that the ads can have detrimental outcomes as well and therefore may require stricter oversight.

“Heightened expectations may lead to inappropriate and costly demands for medications when evidence would dictate other medications or nonpharmacological interventions,” they wrote. “Optimal use of DTCA may require stricter guidelines on advertisements or more aggressive enforcement of current guidelines so that patients do not form unreasonable expectations.”

Stafford said if more stringent oversight ensured “the types of messages (in ads) are narrowed somewhat and are basically well-controlled to make sure patients don’t receive unrealistic expectations, then I think we have a possibility that these sorts of strategies could actually be beneficial.”

On the other hand, Peter Mansfield, director of the non-profit organization Healthy Skepticism, said he thought the ads have more negative consequences than positive and should be banned.

“Almost all government, health professional, and consumer inquiries into DTCA have concluded that it causes net public harm,” Mansfield wrote. “It is too difficult to regulate DTCA, so I believe that the logical conclusion from the evidence is that the best option for improving overall health and wealth is to ban all types of DTCA, including ‘disease awareness’ advertising.”

Mansfield added that “drug company Web sites and media releases should be regulated carefully.”

However, the Pharmaceutical and Research Manufacturers of America maintained that DTCA is vital for patient education.

Trewhitt noted that last year PhRMA’s board of directors approved 15 new principles to make DTCA more educational, and so far 27 pharmaceutical companies have said they will comply with the guidelines.

For example, one of the new guidelines directs companies to submit all new DTCA to the Food and Drug Administration before releasing the ads for broadcast, and another requires drug makers to “spend an appropriate amount of time to educate health professionals about new medicines or new therapeutic indications before beginning the first direct-to-consumer advertising campaign.”

Consumer groups, however, have criticized PhRMA’s guidelines as too weak and called for increased oversight by the FDA.

When the new PhRMA principles were issued last August, Sidney Wolfe, director of Public Citizen’s Health Research Group, called them “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.”

Wolfe urged the FDA to increase its enforcement actions of DTCA and for Congress to pass legislation authorizing the agency to impose large fines on companies that violate laws and regulations that apply to the ads.

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